Clinical Research Associate Ii

Merck; São Paulo; Presencial; BRL 80.000 - 120.000; Tempo integral

Resumo da oferta

A global healthcare company in São Paulo is seeking a Clinical Research Associate II to manage site relationships and ensure compliance with clinical trial protocols. The ideal candidate has a Bachelor's degree and solid experience in clinical research, with fluency in local languages and strong communication skills. This position offers an opportunity to significantly impact healthcare while contributing to the success of clinical trials.

Qualificações

• Solid experience as a Clinical Research Associate, preferably in a similar role.
• Fluent in local languages and advanced proficiency in English (verbal and written).
• Strong understanding of clinical research processes and phases of clinical trials.

Responsabilidades

• Develop and maintain strong relationships with study sites.
• Ensure compliance with regulations and company policies during site management.
• Conduct remote and on-site monitoring to ensure data integrity.

Conhecimentos

Accountability

Adaptability

Clinical Site Management

Data Analysis

Good Clinical Practice (GCP)

Regulatory Compliance

Formação académica

Bachelor’s degree

Ferramentas

MS Office

Clinical Trial Management Systems

Descrição da oferta de emprego

Job Description

Clinical Research Associate II

Are you passionate about clinical research and eager to make a significant impact in the healthcare industry? We are looking for a dedicated Clinical Research Associate III to join our team. In this role, you will be the primary site contact throughout all phases of clinical research studies, ensuring compliance with regulations and contributing to the success of our clinical trials. If you enjoy working with data and technical information, this is the perfect opportunity for you!

As a Clinical Research Associate II, you will play a crucial role in developing and maintaining strong relationships with study sites, facilitating communication, and ensuring that our research protocols are executed effectively. You will have the chance to contribute to the continuous improvement of our clinical research processes.

Main Responsibilities

• Develop and maintain strong relationships with study sites throughout all phases of clinical trials.
• Ensure compliance with International Council for Harmonisation/Good Clinical Practice (ICH-GCP), local regulations, and company policies during site management and monitoring activities.
• Gain a comprehensive understanding of study protocols and related procedures.
• Coordinate tasks with other sponsor roles to achieve “Site Ready” status and participate in site selection and validation activities.
• Conduct remote and on-site monitoring to ensure data integrity and subject safety.
• Document findings accurately during site visits, including initiation, monitoring, and close‑out visits.
• Collect and review regulatory documentation throughout study phases.
• Communicate effectively with investigators and site staff regarding protocol conduct and site performance.
• Identify and resolve site performance or compliance issues, escalating as necessary.
• Manage information in Clinical Trial Management Systems (CTMS) and electronic Trial Master Files (eTMF).
• Act as a Subject Matter Expert (SME) to share best practices and provide training.
• Support audit and inspection activities as needed.

Main Requirements

• Bachelor’s degree
• Solid experience as a Clinical Research Associate, preferably in a similar role.
• Fluent in local languages and advanced proficiency in English (verbal and written).
• Strong understanding of clinical research processes, phases of clinical trials, and ICH‑GCP guidelines.
• Excellent communication skills, with the ability to present technical information effectively.
• Proven skills in site management and patient recruitment.
• Strong analytical skills to understand and act on data and metrics.
• Proficiency in MS Office and clinical IT applications.
• Ability to work independently and manage multiple tasks in a fast‑paced environment.

Required Skills

• Accountability
• Adaptability
• Adverse Event Reporting System
• Clinical Research Methods
• Clinical Site Management
• Clinical Study Management
• Clinical Trial Planning
• Clinical Trials Monitoring
• Data Analysis
• Data Reporting
• Documentations
• Financial Advising
• Good Clinical Data Management Practice (GCDMP)
• Good Clinical Practice (GCP)
• Internal Audit Controls
• Investigation Procedures
• IS Audit
• Key Performance Indicators (KPI)
• Pharmacovigilance
• Process Consulting
• Protocol Adherence
• Quality Management
• Regulatory Compliance
• Regulatory Documents
• + 2 more

Preferred Skills

Current Employees apply HERE

Current Contingent Workers apply HERE

Employee Status: Regular

Relocation: No relocation

VISA Sponsorship: No

Travel Requirements: No Travel Required

Flexible Work Arrangements: Not Applicable

Shift: Not Indicated

Valid Driving License: No

Hazardous Material(s): na

Job Posting End Date: 12/3/2025

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